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NCT Number: NCT05929365

Innovative Approach to Detect Recurrent Colorectal Lesions With Surveillance Via Mutation Analysis & Clinical Phenotype

It is known that the development of colorectal adenoma is dependent on the appearance of somatic mutations in protooncogenes and tumor suppressor genes. Based on our previous mutation analyses of 120 patients with high-risk adenoma removed by enbloc resection with subsequent colonoscopy after 1 year, there is a correlation between mutation in exon 7 of the TP53 gene and risk of early metachronous lesions development. The results also indicate that mutation phenotype (mutation profile and burden) of all lesions detected on index colonoscopy can determine risk of metachronous lesions. As not all synchronous lesions were analyzed and the surveillance colonoscopy interval was less than 3 years, this assumption could not be confirmed. In this study it is planned to perform mutation analysis of all synchronous lesions in 200 patients and correlate the data with appearance of metachronous lesions after 1, 3 and 5 years. Moreover, the mutation profile of all metachronous lesions developed during the 5 years of surveillance will be determinated and compared with mutation profile of index lesions from the same localization to verify their common biological origin. This all could help personalize the surveillance program in terms of reduction of the burden on the patient and endoscopic workplaces and risk of developing colorectal cancer in a particular patient.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Military University Hospital

Prague, 16902, Czechia

Location status: Recruiting

Location contact

Stepan Suchanek, MD., Ph.D.

CONTACT

[email protected]

973208367 ext. 00420

About this study

The aim of this prospective study is to identify patients with recurrent colorectal lesions risk and try to design an optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype. The partial goals are: 1. Determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established PCR/DCE-based heteroduplex method. 2. Clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period. 3. Correlation of clinical and histopathological parameters with mutational phenotype of patient. 4. Correlation of patient's mutational phenotype with an occurrence of metachronous lesion/s during surveillance period. 5. Comparison of the mutation profile of lesions from the index period withthe mutation profile of metachronous lesions. 6. Analysis of the similarity of the mutation profile of lesions found in the same / close areas of the colorectum.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD)
  • Signed informed consent with the study and with colonoscopy

Exclusion criteria

  • FAP, HNPCC and other hereditary CRC syndromes probands
  • Colonoscopy contraindication
  • Severe acute inflammatory bowel disease
  • Severe comorbidities; likely non-compliance of the patient

Treatment and study plan

colonoscopy

Procedure

determine the mutation profile of resected colorectal neoplasia

Other names: endoscopic resection

Primary outcomes

  1. Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype

    Time frame: 5 years

    To identify patients with high risk of metachronous colorectal lesions and try to design and optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype.

Secondary outcomes

  1. Determination of the mutation profile colorectal lesions

    Time frame: 5 years

    Determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established PCR/DCE-based heteroduplex method.

  2. Mutational profil of colorectal lesions

    Time frame: 5 years

    Clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period.

Other outcomes

  1. Mutational phenotype of patient.

    Time frame: 5 years

    Correlation of clinical and histopathological parameters with mutational phenotype of patient.

  2. Metachronous lesions

    Time frame: 5 years

    Correlation of patient's mutational phenotype with an occurrence of metachronous lesion/s during surveillance period.

  3. Similarity of the mutation profile of lesions found in the same area

    Time frame: 5 years

    Analysis of the similarity of the mutation profile of lesions found in the same / close areas of the colorectum.

Study contacts

Contact information is provided by the study sponsor or research team.

Stepan Suchanek, assoc. prof.

CONTACT

[email protected]

973208367 ext. 00420

Tomas Grega, MD, Ph.D.

CONTACT

[email protected]

973203076 ext. 00420

Sponsors and collaborators

Lead sponsor

Military University Hospital, Prague

Other

Registry information

Official study title

Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype

Acronym: MTG

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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